The Oxford University vaccine against COVID-19 being produced by AstraZeneca is likely to get regulatory approval from the UK’s independent regulator by the end of this year for a rollout to begin in early 2021, according to a UK media report.
The Medicines and Healthcare Regulatory Agency (MHRA), which had been formally tasked by the UK government last month with the process of clearance after the jab emerged “safe and effective” against the novel coronavirus in human trials, is expected to authorise the vaccine by December 28 or 29 after the final data is provided on Monday, ‘The Daily Telegraph’ quoted senior government sources as indicating.
“Authorisation by the MHRA will also give confidence to countries across the world. India has already manufactured more than 50 million of the AstraZeneca vaccines,” the newspaper notes.
In India, the vaccine is being produced as part of a tie-up with the Serum Institute of India.
Health officials in the UK hope that the authorisation of the Oxford jab will prove a “game-changer”, allowing vaccines to be transported and administered far more easily compared to the Pfizer/BioNTech vaccine which must be stored at very cold temperatures.
The Oxford vaccine can be stored in normal refrigerators but like the Pfizer vaccine, it also requires two doses – with a three-week gap between the two doses for the Pfizer jabs and a four-week gap for the Oxford/AstraZeneca vaccine.
The Oxford/AstraZeneca, AZD1222, vaccine has taken longer for regulators to assess because of differences in the efficacy rates found in different groups, ranging from 62 to 90 per cent. However, a study released this week suggests that leaving an adequate gap between doses is the most crucial way to boost efficacy, the newspaper reports.
Although the first batch of 4 million doses will be delivered from the Netherlands and Germany, the bulk of manufacturing is set to take place in the UK.
Pharmaceutical giant AstraZeneca has said a further 15 million doses of active ingredients are ready and can be filled into vials in a matter of days, the newspaper report adds.
The full order of 100 million doses, in addition to 40 million doses of the Pfizer jabs being imported from Belgium, is believed to be enough to vaccinate the whole of the UK.